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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03947385




Registration number
NCT03947385
Ethics application status
Date submitted
9/05/2019
Date registered
13/05/2019

Titles & IDs
Public title
Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Scientific title
A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Secondary ID [1] 0 0
IDE196-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Uveal Melanoma 0 0
Cutaneous Melanoma 0 0
Colorectal Cancer 0 0
Other Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IDE196
Treatment: Drugs - Binimetinib
Treatment: Drugs - Crizotinib

Experimental: Dose Escalation Monotherapy - IDE196 dosed orally, twice daily (BID) for each 28-day cycle

Experimental: Dose Expansion Monotherapy - RP2D in MUM and non-MUM tumors harboring GNAQ/11 mutations or PRKC fusions (cutaneous melanoma, CRC, other solid tumors)

Experimental: Dose Escalation Binimetinib Combination - IDE196 dosed orally, twice daily (BID) for each 28-day cycle and Binimetinib dosed orally, twice daily (BID) for each 28-day cycle

Experimental: Dose Expansion Binimetinib Combination - RP2D in MUM and non-MUM tumors harboring GNAQ/11 mutations (cutaneous melanoma, CRC, other solid tumors)

Experimental: Dose Escalation Crizotinib Combination - IDE196 dosed orally, twice daily (BID) for each 28-day cycle and Crizotinib dosed orally, twice daily (BID) for each 28-day cycle

Experimental: Dose Expansion Crizotinib Combination - RP2D in MUM and non-MUM tumors harboring GNAQ/11 mutations (cutaneous melanoma, CRC, other solid tumors)

Experimental: Dose Optimization Crizotinib Combination - IDE196 dosed orally, twice daily (BID) for each 28-day cycle and Crizotinib dosed orally, twice daily (BID) for each 28-day cycle

Experimental: Crizotinib Monotherapy with Crossover to Combination - Crizotinib dosed orally, twice daily (BID) for each 28-day cycle until disease progression then IDE196 added and dosed orally, twice daily (BID) for each 28-day cycle

Experimental: Tablet PK Substudy - IDE196 dosed orally, once on Cycle 1 Day 1; thereafter, twice daily (BID) for each 28-day cycle


Treatment: Drugs: IDE196
IDE196 dosed orally, twice daily for each 28-day cycle

Treatment: Drugs: Binimetinib
Binimetinib dosed orally, twice daily for each 28-day cycle

Treatment: Drugs: Crizotinib
Crizotinib dosed orally, twice daily for each 28-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-limiting Toxicity (DLT)
Timepoint [1] 0 0
28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD)
Timepoint [2] 0 0
28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
Primary outcome [3] 0 0
Recommended Phase 2 Dose (RP2D) as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
Timepoint [3] 0 0
Approx. 6 months
Primary outcome [4] 0 0
Plasma Concentrations of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
Timepoint [4] 0 0
Approx. 6 months
Primary outcome [5] 0 0
Plasma Concentrations of Crizotinib administered in combination with IDE196
Timepoint [5] 0 0
Approx. 6 months
Primary outcome [6] 0 0
Plasma Concentrations of Binimetinib administered in combination with IDE196
Timepoint [6] 0 0
Approx. 6 months
Primary outcome [7] 0 0
Overall Response Rate (ORR) for combination with Binimetinib or in combination with Crizotinib Dose Expansion by Blinded Independent Review Committee
Timepoint [7] 0 0
Approx. 48 months
Primary outcome [8] 0 0
Duration of Response for combination with Binimetinib or in combination with Crizotinib Dose Expansion by Blinded Independent Review Committee
Timepoint [8] 0 0
Approx. 48 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR) for combination with Binimetinib or in combination with Crizotinib in Dose Escalation and all combination cohorts by Blinded Independent Review Committee
Timepoint [1] 0 0
Approx. 48 months
Secondary outcome [2] 0 0
Duration of Response for combination with Binimetinib or in combination with Crizotinib in Dose Escalation and in all combination cohorts by Blinded Independent Review Committee
Timepoint [2] 0 0
Approx. 48 months
Secondary outcome [3] 0 0
ORR by Investigator
Timepoint [3] 0 0
Approx. 48 months
Secondary outcome [4] 0 0
Duration of Response by Investigator
Timepoint [4] 0 0
Approx. 48 months
Secondary outcome [5] 0 0
Disease Control by Investigator
Timepoint [5] 0 0
Approx. 48 months
Secondary outcome [6] 0 0
Numbers of Participants with Adverse Events
Timepoint [6] 0 0
Approx. 48 months
Secondary outcome [7] 0 0
Treatment-related pharmacodynamic effect in all patients
Timepoint [7] 0 0
Approx. 48 months

Eligibility
Key inclusion criteria
* Patient must be =18 years of age
* Diagnosis of one of the following:

* MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Or
* Non-MUM: Advanced cutaneous melanoma, colorectal cancer, or other solid tumor that has progressed following prior standard therapies or that has no satisfactory alternative therapies and has evidence of GNAQ/11 hotspot mutation
* Measurable disease
* Eastern Cooperative Oncology Group =1 and expected life expectancy of > 3 months
* Adequate organ function at screening
* Adequate contraceptive measures for non-sterilized male and female patients of childbearing potential

Binimetinib Combination Additional

• Adequate cardiac function represented by left ventricular ejection fraction (LVEF) = 50%

Crizotinib Combination Additional

* Prior chemotherapy other therapies as applicable or major surgeries must have been completed at least 4 weeks prior to initiation of crizotinib
* Patients with preexisting peripheral neuropathy can be included if it is Grade 1 or lower, prior to initiation of crizotinib
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known symptomatic brain metastases
* Previous treatment with a PKC inhibitor
* Known MSI-H/dMMR tumors who have not previously received immune checkpoint inhibitors
* Adverse events from prior anti-cancer therapy that have not resolved
* Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus
* Active infection requiring ongoing therapy
* Recent surgery or radiotherapy
* Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect
* Females who are pregnant or breastfeeding
* Impaired cardiac function
* Treatment with prohibited medications that cannot be discontinued prior to study entry
* For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin

Binimetinib Combination Additional Exclusion Criteria

* Prior treatment with a MEK inhibitor
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
* History of interstitial lung disease
* History of thromboembolic or cerebrovascular events = 12 weeks prior to first dose
* Concurrent neuromuscular disorders that are associated with elevated creatine phosphokinase (CPK)
* Uncontrolled arterial hypertension despite medical treatment
* Allergy to binimetinib or its components
* History of syncope

Crizotinib Combination Additional

* Prior therapy directly targeting ALK, MET, or ROS1
* Spinal cord compression
* History of pneumonitis or interstitial lung disease
* History of syncope

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
278
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
IDEAYA Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jasgit Sachdev, MD
Address 0 0
[email protected]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
IDEAYA Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
+1 650 534 3616
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03947385